Summary
The FDA issued a Class I for Clean Catch Urine Kit NS 178489, AHMU58A by American Contract Systems, Inc.. Reason: Affected products were assembled off-site by individuals who may not have been properly trained..
Details
Source
Device Recall
External ID
Z-1276-2022
Action Date
2022-07-13
Status
Ongoing
Category
device
Product Description
Clean Catch Urine Kit NS 178489, AHMU58A
Lot/Code Info: UDI-DI: 00191072120557 Lots 891211, 737211, 699211, 986221
Quantity Affected: 274,400 kits total
Reason for Recall
Affected products were assembled off-site by individuals who may not have been properly trained.
Distribution
US distribution in the state of Minnesota.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-02
Company
Kansas City, MO
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 120 device recalls issued in the same week, part of 403 device-related FDA actions this month.
American Contract Systems, Inc. has 188 FDA actions in our database, including 188 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (American Contract Systems, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does American Contract Systems, Inc. have FDA actions?
American Contract Systems, Inc. has 188 FDA actions in our database, including 188 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1276-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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